Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs
to Provide Immune Support Against Coronavirus Disease. 75 patients will be enrolled. All
patients have previously banked their own mesenchymal stem cells at Hope Biosciences.
Eligible participants are either over 50 years of age, have preexisting conditions, or are at
high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide
immune support against COVID-19, measured by the percentage of participants in each category
of a 7-point ordinal scale and the presence or absence of adverse events and serious adverse
events related to the study drug. In addition, participants will be monitored for overall
clinical status by standard clinical laboratories and inflammatory markers. Participants will
complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
Biological: HB-adMSCs
Five IV infusion of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2,6,10,14,18,22,26.
Inclusion Criteria:
Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.
1. Men, and women over 65 years of age inclusively (according to CDC provisions) OR
2. Participant works in healthcare facility or other well characterized high-risk
environment OR
3. Has underlying conditions including but not limited to cardiopathies, diabetes
mellitus, cancer, COPD, asthma or any other systemic autoimmune disease.
4. Subject must have previously banked their cells at Hope Biosciences
5. No signs or symptoms of infection, including but not limited to, body temperature >100
F and pulse rate > 100 BPM.
6. Subject provides written informed consent prior to initiation of any study procedures.
7. Agrees to the collection of venous blood per protocol.
Exclusion Criteria:
Subjects must not have any of the following criteria to be eligible.
1. Patients who are participating in other clinical trials or have intake of
investigational drug within the previous 30 days;
2. Inability to provide informed consent or to comply with test requirements;
3. Any medical disease or condition that, in the opinion of the site PI or
sub-investigator, precludes study participation. Including acute, subacute,
intermittent or chronic medical disease or condition that would place the subject at
an unacceptable risk of injury, render the subject unable to meet the requirements of
the protocol, or may interfere with the evaluation of responses or the subject's
successful completion of this trial.
4. Patients who have received a stem cell treatment within one year.
5. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time
prior to or during the study.
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States
Thanh Cheng, MD, Principal Investigator
Hope Biosciences Stem Cell Research Foundation